Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

NCT05450042 | Unknown FDA Device

• 1 other identifier: The Limus FLOW Study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.

Conditions

Peripheral Arterial Disease; Flow-mediated Dilation; Drug Eluting Balloon; Infrainguinal Peripheral Arterial Disease

Keywords

Paclitaxel eluting ballon; Sirolimus eluting ballon; Percutaneous transluminal angioplasty

Outcome Measures

Primary Outcomes (3)

• Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure

  FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery

  1 month

• Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure

  FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery

  6 months

• Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure

  FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery

  12 months

Secondary Outcomes (13)

• Changes in pulse wave velocity (PWV)

  Baseline, followed at 1, 6 and 12 months

• Changes in augmentation index

  Baseline, followed at 1, 6 and 12 months

• Changes in vascular strain

  Baseline, followed at 1, 6 and 12 months

• Changes in peripheral perfusion determined by ABI (ankle brachial index)

  Baseline, followed at 1, 6 and 12 months

• Primary patency (PP) of target lesion

  Baseline, followed at 1, 6 and 12 months

Study Arms (2)

SELUTION SLR DCB

EXPERIMENTAL

Sustained Limus Release drug eluting balloon

Device: SELUTION SLR DCB

Paclitaxel eluting balloon

ACTIVE COMPARATOR

Conventional: Medtronic INpact

Device: Paclitaxel DCB

Interventions

SELUTION SLR DCB DEVICE

Sirolimus DCB

SELUTION SLR DCB

Paclitaxel DCB DEVICE

Paclitaxel DCB

Paclitaxel eluting balloon

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peripheral artery disease
• Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions
• Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
• Planed peripheral intervention TASC A-D
• Subject must be between 18 and 85 years old
• Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation
• Vessel diameter ≥4.0 mm and ≤7.0 mm
• Willing to comply with the specified follow-up evaluation
• Written informed consent prior to any study procedures
• Pretreatment with an adequately sized balloon

You may not qualify if:

• Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement
• Instent-Restenosis
• Thrombolysis within 72 hours prior to the index procedure
• Aneurysm formations in the femoral artery or popliteal artery
• Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
• Unstable angina pectoris at the time of the enrollment
• Recent myocardial infarction or stroke \< 30 days prior to the index procedure
• Life expectancy less than 12 months

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University of Essen, Clinic of Cardiology and Angiology

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christos Rammos, Professor

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Rammos, Professor

CONTACT

0201-723-84808; christos.rammos@uk-essen.de

Tienush Rassaf, Univ.-Prof.

CONTACT

0201-723-4801; tienush.rassaf@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. C. Rammos, MD, FESC, MHBA

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: July 8, 2022
• Study Start: April 6, 2022
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

DE (1)